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Abstract

ABSTRACT The oral delivery of lipophilic drugs presents a major challenge due to low aqueous solubility of such compounds. Clopidogrel is a BCS class II prodrug specifically and irreversibly inhibits the platelets aggregation by blocking activation of the glycoprotein IIb /IIIa pathway. The chief intention of this work is to develop an orally stable self Nano-emulsifying drug delivery system by evaluating its in vitro potential. Components of SNEDDS were assessed by solubility studies on various oils, surfactant, co-surfactants and co solvents. Ternary phase diagrams were constructed to identify area of nanoemulsification for the selected systems. Characterization of SNEDDS was done by Physical method, Droplet size, Zeta potential determination, drug loading capacity, Transmission test, Cloud point measurement and in vitro release study. The optimal Formulation consisted of mixture of Drug (13.05%), Acrysol K150 and PEG 400 (1:1) and Capmul MCM NF (17.39%). Droplet size of optimal batch was 22.91 nm with PdI 0.173.Drug loading capacity was 2 times the Actual dose of CLP (75 mg). Transmission values were above 99% in pH 1.2, Ph 6.8 and distilled water. Cloud point of formulations was above 65°C. In vitro release inspection of optimal formulation illustrated a complete release of Clopidogrel from SNEDDS within 15 min. Our study concludes that the SNEDDS shows potential approach for the poorly water soluble drugs including Clopidogrel